FDA Medical Device Recalls (openFDA)
EEG Info: EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
- Recall number
- Z-0526-2013
- Recalling firm
- EEG Info
- Product
- EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
- Status
- Terminated
- Initiated
- 2012-11-15
- Posted
- 2012-12-17
- Terminated
- 2013-06-11
- Reason
- EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.
- Root cause
- Labeling False and Misleading
- Action
- EEGInfo sent a recall notification letterdated November 29, 2012, to all affected customers. The letter informed the customers they have not received approval from the FDA to market and distribute a device for therapeutic applications other than that of its FDA intended use-biofeedback relaxation. Customers are informed that the safety and effectiveness for other indications has not been established. The risk or likelihood of serious adverse health consequences is remote. Customers were instructed to forward this notice if affected product was further distributed. Customers with questions about the notification letter are instructed to contact EEG Info's customer support line during normal business hours, Monday-Friday, from 8am-5pm PST. For questions regarding this recall call 818-456=5965.
- Quantity
- 1308 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Serial Number: 0001-3343.
- 510(k) numbers
- ["K073557"]
- PMA numbers
- not on file
- Product code
- HCC
- Firm FEI
- 3009138210
- Firm city
- Woodland Hills
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28